FDA Cosmetic Registration in Bangkok, Thailand

Cosmetic import and manufacturing is regulated by Cosmetic act 2015 in Thailand under which cosmetic means,

1. Substance intended for use in applying, rubbing, massaging, sprinkling, spraying, dropping, putting on, perfuming, or acting by whatever means on external human body and shall include the use on tooth and oral mucosa with the objective of cleaning, beautifying, or changing appearance or deodorizing or protecting such parts in good condition, and as well as skin treatment product, but not include adornment and dress which is an accessory for use on external body;
2. Substance intended for use specifically as a mixture in producing cosmetic product.

Import or manufacturing of cosmetic product

Any company or an individual who wants to import cosmetics product for sale or manufacturer cosmetic product for sale in the kingdom of must inform about the details of cosmetic product to be imported or manufactured to the concern authority.

The submission and issuance of Import permit or information receipt should strictly follow the regulation and condition as specified by ministerial regulation of Ministry of Public Health.

The import permit or manufacturing permit or information receipt is issued by Cosmetic division of Thai FDA. Once issued it is valid for the period of 3 years from the date of issue.

Renewal of such permit should be applied before the expiry of the information receipt.

Thai FDA implies following regulatory measure to ensure quality and safety of cosmetic product manufactured or imported in Thailand:

Pre-marketing controls:

Technical Requirements of Cosmetics

The technical requirements cover the positive and negative listings of ingredients, labeling and claims, pre-marketing requirements, and Good Manufacturing Practices (GMP). These technical requirements serve as the guidelines for quality and safety control.

Under the current cosmetic regulation, cosmetics will require the notification of the products to FDA prior to being manufactured or imported in Thailand.
Before the cosmetic product are imported or manufactured and launched in the market there are some requirement that should be met by both importer and manufacturer which are outlined as below:

1.  Notify the information of cosmetic products to the FDA department Cosmetic division prior to producing or importing.  Once the information supplied is completed and correct, the applicant will receive the notification receipt which is valid for 3 years. 

2.  Manufacture or import the cosmetic product following the instruction or specification in accordance to the notification.

3.  Prepare label: Label Information must have written or printed be in Thai language and must be the size that is easily readable and understandable. The contents must be the accurate and must not be deceptive. References should be documented for inspection.

4.  Advertise the cosmetic product based on its fact without misleading contents.  References should be documented for inspection.

Details of information required for notification includes:

1.  Applicants are manufacturer (repackaging included), original equipment manufacturer, and importer. 
2.  Information for notification includes:

• Information of the applicant such as name and address of manufacturer or importer or storage site, manufacturing site,
• Information of the cosmetic product such as name, Brand name (Trade name), categories and ingredients.
• Submitting an application from for notifying (Form Jor Kor)

If the manufacturing or storage sites are located in Bangkok, the manufacturers or the importers must notify at the Food and Drug Administration office.  If the manufacturing or storage sites are located in other provinces, the manufacturers or the importers must notify at the provincial public health office where the sites are located.

Labelling requirement for Cosmetic Product:

As stipulated by cosmetic department the cosmetic product manufactured or imported in Thailand must be labelled clearly covering the following details aspect of product specification.

1. Product name and Brand Name
2. Type of product, categories
3. All ingredients
4. Instruction for use
5. Name and address of manufacturer (Name and address of importer including name of manufacturer and country of origin)
6. Net content
7. Batch Number
8. Manufacturing date
9. Expiry date
10. Statutory Warning
11. Notification number

Any Claims in labelling or advertisement must not indicate that the products have any pharmaceutical characteristics or capability to affect or alter human body's functions or structure. Moreover, these claims must not indicate that those cosmetic products have the capability which, in fact, does not exist or is the cause of misunderstanding in their quality. The labels of cosmetic products may contain the claims of use within the scope of cosmetics similar to those claims shown in advertising. However, the manufacturers or importers must retain the profile of product information including the evidence supporting such claims.

Post Marketing control:

Once the cosmetic products launched in the market Thai FDA performs it supervisory and monitoring role concentrating in mainly five different areas namely

• Inspection: The activities under control through inspection, includes inspection and product sampling, carried out in accordance with the annual plan and in response to the complaints or reports of adverse reactions or surveillance.

• Market surveillance: Market surveillance is performed anytime round the year which is concerned with investigating product labeling and the collection of marketed product samples at the inspected place. All claims imprinted on the labels of cosmetic products must have the supporting evidence kept in a ready-to-be-delivered manner.

• Advertisement investigation: Advertisements of cosmetic products essentially indicate the products' benefits pertaining to cosmetic scope and purposes. Cosmetic claims are prohibited from indicating that the products have any pharmaceutical characteristics or capability to affect or alter human body's functions or structure. Such claim will put the product into drug category. Furthermore, all advertisements must not claim nor indicate in any way that those cosmetic products have the capability which, in fact, does not exist or is the cause of misunderstanding in their quality.

• Adverse product reaction surveillance:  This activity aims to detect any adverse effects or unexpected outcomes from consumer use of products.  Data on adverse effects, including technical information, are collected, summarized, interpreted and reported. These activities are preformed through Product Adverse Product Reaction Monitoring Center (APRMC) and the International Program on Chemical Safety (IPCS).

• Improvement of manufacture: The Good Manufacturing Practices guidelines are designated to help the manufacturers to improve or develop their practices in manufacturing cosmetic products. The guidelines cover various topics, namely definitions, personnel, premises, sanitation, equipment, raw materials and packaging materials, production procedures, quality control, documentation, product recall, internal audit, recording of product distribution, complaints and report of adverse product reaction, and product return.

The manufacturers and the Thai Food and Drug Administration (FDA) use these guidelines as a standard for their operations and inspection to ensure the standard of quality of products manufactured.

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